FDA.reportPublic FDA data

AincA

Primary DI
B005004220
Brand
AincA
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-422
Catalog number
00-422
Device description
"Valve, Non-Rebreathing, 90°, Adjustable Pop-Off, 7/8"" x 22mmM/15mmF, w/Thumb Control, Chrome Brass"
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B005004220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, reusableA non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(760) 744-6561Solutions@AincA.com

Regulatory Flags#

DUNS number
002065670
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B005002370AincA®00-23700-2372021-03-31
B005002380AincA®00-23800-2382021-03-31
B005004070AincA®00-40700-4072021-03-31
B00500407S0AincA®00-407-S00-407-S2021-03-31
B005004080AincA®00-40800-4082021-03-31
B00500408S0AincA®00-408-S00-408-S2021-03-31
B00500675A0AincA®00-675-A00-675-A2021-03-31
B00500675A10AincA®00-675-A-100-675-A-12021-03-31
B00500675B0AincA®00-675-B00-675-B2021-03-31
B00500675B10AincA®00-675-B-100-675-B-12021-03-31
B00500675BDEMO0AincA®00-675-B-DEMO00-675-B-DEMO2021-03-31
B00500675C0AincA®00-675-C00-675-C2021-03-31
B00500675C10AincA®00-675-C-100-675-C-12021-03-31
B00500675CASE0AincA®00-675-CASE00-675-CASE2021-03-31
B00500675LCD0AincA®00-675-LCD00-675-LCD2021-03-31
B00500675V0AincA®00-675-V00-675-V2021-03-31
B00500675V10AincA®00-675-V-100-675-V-12021-03-31
B005LF143B0AincA®LF-143-BLF-143-B2021-03-31
B005LF143C0AincA®LF-143-CLF-143-C2021-03-31
B005003800AincA®00-38000-3802021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946430427199CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-08-08
06946430426185GFAXIAMEN COMPOWER MEDICAL TECH. CO., LTDCBP2026-06-01
B448260103XpectFirstar Healthcare Company Limited (Guangzhou)CBP2026-05-13
10889483570562AirLife™AIRLIFECBP2025-03-28
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
0076658801349724M - Tampa Electric Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658802201724M - Salt River Project-21 - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588030111XLP - Toyota - Black - XLPouchCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588049045HSB - BBP - Southern Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658806057625M - First Aid Kit - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658806123824PW - Turtle Top Florida DOT - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588070650EMT Trauma Care - Red Cordovia BagCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658808074136M - Enbridge - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658809053510PC - Rail America Locomotive - PolyCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588090610Emergency Trauma Care Deluxe - Orange Co-Polymer CaseCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588100029Sports Bag - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810093710PW - Head Start - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588107042SB-2 - Head Start - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810957210M - Sempra - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658811012710PC - UP - 380-54620 - LocamotiveCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812001010M - State of South Dakota DOT BBP - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812068310PW - Hawaiian TelecomCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812072018PR - First Aid Complete Kit - Poly RedCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812082916PW - PCI Construction - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588121079FAC-4 - Miller & Long ConcreteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812966275V - UP Facilities - RefillCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813049136M - PacifiCorp - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15